Bristol-Myers Squibb Company recently announced that the U.S. Food and Drug Administration (FDA) has approved updates to the labels of its CAR T cell therapies, Breyanzi® and Abecma®. These updates involve streamlined patient monitoring requirements and the removal of the Risk Evaluation and Mitigation Strategy (REMS) programs. The decision reflects a growing confidence in the safety profile of these therapies, which target CD19 and BCMA, respectively. This regulatory change is expected to reduce barriers for patients and providers, potentially increasing access to cell therapy treatments. Bristol-Myers Squibb remains the only company with two approved CAR T cell therapies targeting distinct areas, continuing its leadership in the field of cell therapy.
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